Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 study of VK2809 in patients with hypercholesterolemia and fatty liver disease. VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue as well as the beta receptor subtype, suggesting promising therapeutic potential in this patient population. Viking expects to initiate the Phase 2 clinical trial by the end of 2015.
The planned Phase 2 study will be a randomized, double-blind, parallel group, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of VK2809 in approximately 100 patients with elevated LDL cholesterol (LDL-C) and fatty liver disease. Patients will be randomized to receive once-daily doses of VK2809 or placebo for 12 weeks. The trial's primary endpoint will evaluate the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. Secondary and exploratory endpoints will assess changes in liver fat content, triglycerides, and inflammatory markers. Viking expects to complete the study in 2016.
"We are eager to evaluate the therapeutic impact of VK2809 in patients with hypercholesterolemia and fatty liver disease," said Brian Lian, Ph.D., chief executive officer of Viking. "Prior human data suggest that treatment with VK2809 leads to significant reductions in LDL-C, triglycerides, and atherogenic proteins. In addition, animal models of hepatic steatosis have demonstrated compelling reductions of liver fat content following treatment. VK2809's novel liver-targeted mechanism of action provides a unique opportunity to potentially improve plasma lipid levels and reduce hepatic steatosis simultaneously, which may provide important therapeutic benefits for patients. Together with our recently-initiated Phase 2 clinical trial of VK5211, our lead program for muscle and bone disorders, the Phase 2 VK2809 study will represent the second key clinical trial we will have underway by year-end. We believe we are making excellent progress toward our goal of unlocking substantial value from our pipeline programs."